Evidence map›Paper›PMID 26195515›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Plasma Tenofovir, Emtricitabine, and Rilpivirine and Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate Pharmacokinetics following Drug Intake Cessation.

Laura Dickinson, H Manisha Yapa, Akil Jackson, Graeme Moyle, Laura Else, Alieu Amara, Saye Khoo, David Back, Zeenat Karolia, Chris Higgs and 1 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Laura DickinsonDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom laurad@liv.ac.uk.
H Manisha YapaSt Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
Akil JacksonDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom St Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
Graeme MoyleSt Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
Laura ElseDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
Alieu AmaraDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
Saye KhooDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
David BackDepartment of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
Zeenat KaroliaSt Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
Chris HiggsSt Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
Marta BoffitoSt Stephen's Centre, Chelsea & Westminster Foundation Trust, London, United Kingdom.
University of Liverpool · GBChelsea and Westminster Hospital NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacokinetic (PK) data describing a prolonged time course of antiretrovirals in plasma and peripheral blood mononuclear cells (PBMCs) are important for understanding and managing late or missed doses and to assess the appropriateness of compounds for preexposure prophylaxis (PrEP). This study aimed to evaluate the PK of coformulated tenofovir disoproxil fumarate (DF), emtricitabine, and rilpivirine in plasma and of the intracellular (IC) anabolites tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in healthy volunteers up to 9 days after drug cessation. Individuals received daily tenofovir DF-emtricitabine-rilpivirine (245/200/25 mg) for 14 days. Drug intake was stopped, and serial sampling occurred prior to the final dose and up to 216 h (9 days) after stopping drug intake. Concentrations were quantified and PK parameters calculated. Eighteen volunteers completed the study. The terminal elimination plasma half-lives for tenofovir and emtricitabine over 216 h (geometric mean [90% confidence interval]) were higher than those seen over 0 to 24 h (for tenofovir, 31 h [27 to 40 h] versus 13.3 h [12.5 to 15.1 h]; for emtricitabine, 41 h [36 to 54 h] versus 6.4 h (5.9 to 7.6 h]). Model-predicted IC half-lives (0 to 168 h) were 116 h (TFV-DP) and 37 h (FTC-TP). The plasma rilpivirine concentration at 216 h was 4.5 ng/ml (4.2 to 6.2 ng/ml), and half-lives over 0 to 216 h and 0 to 24 h were 47 h (41 to 59 h) and 35 h (28 to 46 h), respectively. These data contribute to our understanding of drug behavior following treatment interruption; however, adherence to therapy should be promoted. Validated plasma and IC target concentrations are necessary to allow interpretation with respect to sustained virus suppression or HIV prevention. (The trial was conducted in accordance with the Declaration of Helsinki [EudraCT 2012-002781-13].).

Indexed as

AdenineAdolescentAdultAgedAnti-HIV AgentsEmtricitabineFemaleHIV InfectionsHumansMiddle AgedOrganophosphatesRilpivirineTenofovirYoung AdultAdenineAnti-HIV AgentsEmtricitabineOrganophosphatesRilpivirineTenofovirtenofovir diphosphate

Identifiers

PMID26195515
PMCPMC4576083
OpenAlexW2151816247

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.